As you know, the Supreme Court issued its opinion in Mayo v. Prometheus, an important intellectual property case for biotech.  The Court held that the correlation between blood test results and patient health is not patentable.

Under Prometheus, new patents involving correlations between natural phenomena must do more than simply recite the natural correlation and then tell the user to apply it. Rather, correlation patents must confine themselves to particular applications of these correlations applied in new ways and not simply using well-known steps. In addition, Prometheus rejected a “look ahead’ approach that would allow courts to get around the patentable subject matter question by changing to an analysis of patentability under 35 U.S.C. Sections 102 or 103.

The case mainly concerned the status of the machine-or-transformation test when determining patent eligibility:

On remand, the Federal Circuit characterized the central question as whether Prometheus’s claims are drawn to a natural phenomenon, the patenting of which would entirely preempt its use, or whether the claims are only drawn to a particular application of the phenomenon.  Mayo argued, before the Federal Circuit and again this past week before the Supreme Court, that this was the sole controlling standard, and that Bilski stood for the proposition that, while the machine-or-transformation test is a helpful clue, it cannot be outcome-determinative in this analysis.   According to Mayo, even if the claims passed the machine-or-transformation test, more analysis, such as a robust preemption analysis, would be necessary to make a subject-matter eligibility determination.  Prometheus, on the other hand, argued that the Bilski ruling only meant that patents which did not satisfy the machine-or-transformation test were not necessarily unpatentable, but did not go so far as to say that some patents that do satisfy the test are unpatentable.

An earlier judgment was vacated and the case remanded to the U.S. Court of Appeals for the Federal Circuit for further consideration in light of Bilski v. Kappos, 561. The Federal Circuit, reversing the district court, upheld Prometheus’s patent claims covering a means to measure the level of 6-thioguinine (6-TG) and 6-methylmercaptopurine (6-MMP), which indicates that an adjustment in drug dosage may be required at certain metabolite levels.

The district court decided as a matter of law that the asserted claims were drawn to non-statutory subject matter and as such, unpatentable.  However, the Federal Circuit held that methods of treatment claims fall within the realm of patentable subject matter. Prometheus Laboratories, Inc. v. Mayo Collaborative Services (08-1403).

In Mayo v. Prometheus, the Supreme Court emphasized the concern over patents that disproportionately tie up the use of underlying natural laws, thereby inhibiting their use in the making of further discoveries, particularly in fields not contemplated by the patentee.

The Court stated, “to transform an unpatentable law of nature into a patent-eligible application of such a law, a patent must do more than simply state the law of nature while adding the words ‘apply it.’”

Further, the Court stated, “the claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine application of those laws rather than drafting efforts designed to monopolize the correlations”.

Held: Prometheus’ process is not patent eligible.

Justice Breyer delivered the opinion for a unanimous Court:

(a) Because the laws of nature recited by Prometheus’ patent claims—the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm—are not themselves patentable,the claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations. The three additional steps in the claimed processes here are not themselves natural laws but neither are they sufficient to transform the nature of the claims. The “administering” step simply identifies a group of people who will be interested in the correlations, namely, doctors who used thiopurine drugs to treat patients suffering from autoimmune disorders. Doctors had been using these drugs for this purpose long before these patents existed. And a “prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment.’ ” Bilski, supra, at ___. The “wherein” clauses simply tell a doctor about the relevant natural laws, adding, at most, a suggestion that they should consider the test results when making their treatment decisions. The “determining”step tells a doctor to measure patients’ metabolite levels, through whatever process the doctor wishes to use. Because methods for making such determinations were well known in the art, this step simply tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field. Such activity is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law. Parker v. Flook, 437 U. S. 584, 590. Finally, considering the three steps as an ordered combination adds nothing to the laws of nature that is not already present when the steps are considered separately.

(b) A more detailed consideration of the controlling precedents reinforces this conclusion.

  1. Diehr and Flook, the cases most directly on point, both addressed processes using mathematical formulas that, like laws of nature, are not themselves patentable. In Diehr, the overall process was patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole. These additional steps transformed the process into an inventive application of the formula. But in Flook, the additional steps of the process did not limit the claim to a particular application, and the particular chemical processes at issue were all “well known,” to the point where, putting the formula to the side, there was no “inventive concept” in the claimed application of the formula. 437 U. S., at 594. Here, the claim presents a case for patentability that is weaker than Diehr’s patent-eligible claim and no stronger than Flook’s unpatentable one. The three steps add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field. Pp. 11–13.
  2. Further support for the view that simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws,phenomena, and ideas patentable is provided in O’Reilly v. Morse, 15 How. 62, 114–115; Neilson v. Harford, Webster’s Patent Cases 295, 371; Bilski, supra, at ___–___; and Benson, supra, at 64, 65, 67. Pp. 14–16.
  3. This Court has repeatedly emphasized a concern that patent law not inhibit future discovery by improperly tying up the use of laws of nature and the like. See, e.g., Benson, 409 U. S., at 67, 68. Rewarding with patents those who discover laws of nature might encourage their discovery. But because those laws and principles are “the basic tools of scientific and technological work,” id., at 67, there is a danger that granting patents that tie up their use will inhibit future innovation, a danger that becomes acute when a patented process is no more than a general instruction to “apply the natural law,”or otherwise forecloses more future invention than the underlying discovery could reasonably justify. The patent claims at issue implicate this concern. In telling a doctor to measure metabolite levels and to consider the resulting measurements in light of the correlations they describe, they tie up his subsequent treatment decision regardless of whether he changes his dosage in the light of the inference he draws using the correlations. And they threaten to inhibit the development of more refined treatment recommendations that combine Prometheus’ correlations with later discoveries. This reinforces the conclusion that the processes at issue are not patent eligible, while eliminating any temptation to depart from case law precedent. Pp. 16–19.

(c) Additional arguments supporting Prometheus’ position—that the process is patent eligible because it passes the “machine or transformation test”; that, because the particular laws of nature that the claims embody are narrow and specific, the patents should be upheld;that the Court should not invalidate these patents under §101 because the Patent Act’s other validity requirements will screen out overly broad patents; and that a principle of law denying patent coverage here will discourage investment in discoveries of new diagnostic laws of nature—do not lead to a different conclusion.

628 F. 3d 1347, reversed.

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